Direct Pulp Capping in Primary Molars

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-06-06

Brief Summary

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The purpose of this study is to Assess the effect of MTA and hard setting Calcium Hydroxide (Dycal) on the clinical and radiographic outcome of direct pulp capping in primary molars and evaluate overall success rate of direct pulp capping in primary molars.

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Detailed Description

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After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in patient examination sheet.

Participants who met the inclusion criteria were randomly allocated to two groups (n = 26/group, N = 52 in total) according to the capping martials using the envelope randomization method.

2 study groups according to capping material that will be used (Dycal or MTA) and each group will be divided to 2 subgroups according to site of exposure axial or pulpal.

All patients were recalled and their treated molars were evaluated clinically and radiographically at 3months, 6months, 9months ,12months follow up periods.

Conditions

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Direct Pulp Capping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in patient examination sheet. Participants who met the inclusion criteria were randomly allocated to two groups (n = 26/group, N = 52 in total) according to the capping martials using the envelope randomization method. All patients were recalled and their treated molars were evaluated clinically and radiographically at 3months, 6months, 9months ,12months follow up periods.

2 study groups according to capping material that will be used (Dycal or MTA) and each group will be divided to 2 subgroups according to site of exposure axial or pulpal

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

capping material used

Study Groups

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Mineral trioxide aggregate (MTA)

* where the pulp tissue is exposed during final caries removal, hemostasis will be achieved by cavity irrigation with sterile saline solution for up to 4 minutes till control of bleeding
* Teeth with pulp exposure less than 1mm in diameter surrounded by sound dentin will be candidates for direct pulp capping
* Following the removal of the saline, the exposed pulp will be irrigated with 17% EDTA solution (Prevest Direct, India) for 1 minute
* According to site of exposure, the groups will be further subdivided into Group A (n=13) with exposure in pulpal floor and Group B (n=13) with exposure in axial wall of the cavity.
* Exposed pulp will be covered with fast set MTA paste after cavity dryness with sterile cotton pellet then the tooth will be restored with Self-cured glass ionomer restorative material (SDI Riva self-cure, Australia) and tooth will be covered by stainless steel crown

Group Type ACTIVE_COMPARATOR

Mineral trioxide aggregate (MTA)

Intervention Type OTHER

Materials for Vital Pulp Capping

Hard setting Calcium Hydroxide (Dycal)

* where the pulp tissue is exposed during final caries removal, hemostasis will be achieved by cavity irrigation with sterile saline solution for up to 4 minutes till control of bleeding
* Teeth with pulp exposure less than 1mm in diameter surrounded by sound dentin will be candidates for direct pulp capping
* Following the removal of the saline, the exposed pulp will be irrigated with 17% EDTA solution (Prevest Direct, India) for 1 minute
* According to site of exposure, the groups will be further subdivided into Group A (n=13) with exposure in pulpal floor and Group B (n=13) with exposure in axial wall of the cavity.
* Exposed pulp will be covered with Dycal paste after cavity dryness with sterile cotton pellet then the tooth will be restored with Self-cured glass ionomer restorative material (SDI Riva self-cure, Australia) and tooth will be covered by stainless steel crown

Group Type ACTIVE_COMPARATOR

Hard setting Calcium Hydroxide (Dycal)

Intervention Type OTHER

Materials for Vital Pulp Capping

Interventions

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Mineral trioxide aggregate (MTA)

Materials for Vital Pulp Capping

Intervention Type OTHER

Hard setting Calcium Hydroxide (Dycal)

Materials for Vital Pulp Capping

Intervention Type OTHER

Other Intervention Names

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BIO MTA CERKAMED, Poland Dycal Promedica Urbical, Germany

Eligibility Criteria

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Inclusion Criteria

* Cooperative child and compliant parent.
* Complete physical and mental health.
* Children who are known to be healthy and free from systemic diseases.
* Primary molars with deep carious lesions leading to pathological exposure but with no signs or symptoms of irreversible pulpitis or necrosis such as spontaneous pain, tenderness to percussion, abscess, fistula, periodontal tissue swelling, or abnormal tooth mobility.

Exclusion Criteria

* A deep carious lesion in close proximity to the pulp with an intact lamina dura.
* Absence of widening of periodontal membrane space or radiolucency at the furcation and periapical region.
* Absence of pulpal calcifications, obliteration of the pulp and root canal, or internal/external root resorption.

Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes